BAL HARBOUR, FLA., June 17, 2003 -- Opiate addicts treated with
a combination of lofexidine and an opiate antagonist are more
likely to remain opiate-free and suffer no significant adverse
effects, according to a pilot study performed at Yale University
School of Medicine and presented at the College on Problems of Drug
Dependence's 65th Annual Scientific Meeting.

"Preventing relapse and reducing stress associated with relapse
is vital to the overall success of an opiate addiction treatment
program," said Rajita Sinha, PhD, Associate Professor, Department
of Psychiatry, and Director of the Substance Abuse Treatment Unit
at Yale University, who conducted the study. "The addition of
lofexidine proved to be effective in ensuring that trial subjects
complied with their treatment regimens and remained on the path to
becoming opiate free."

Lofexidine, an alpha-2-adrenergic agonist, is a non-opiate,
non-addictive treatment that reduces the symptoms associated with
withdrawal such as chills, sweating, stomach cramps, emesis,
diarrhea, muscle pain, and runny nose and eyes. Lofexidine has been
available in the United Kingdom since 1991 and is marketed under
the name BritLofex by Britannia Pharmaceuticals.

In the two-phase, 8-week Yale study, researchers sought to
evaluate how the addition of lofexidine would affect subjects
involved in orally administered opiate antagonist treatment. The
opiate antagonist used in the study is a drug prescribed to help
people maintain abstinence after they have detoxified (withdrawn)
from heroin or other opioids.

In Phase I of the study, subjects were given varying doses of
lofexidine in combination with the opiate antagonist. Seventy-two
percent of subjects completed the four-week phase and the
lofexidine/opiate antagonist combination was found to be tolerable
and without any significant adverse events.

In Phase II, subjects were randomized to either remain on
lofexidine or be tapered to placebo, in a double-blind placebo
controlled manner, while remaining on a consistent dose of the
opiate antagonist. Researchers found that subjects treated with the
combination lofexidine/opiate antagonist were significantly more
likely to remain opiate-free, were more compliant with taking the
daily opiate antagonist, and had decreased cravings and lower
perceived stress as compared to the subjects who received the
placebo.

"The fact that the majority of subjects experienced no side
effects or withdrawal symptoms with lofexidine is extremely
encouraging," added Thomas Kosten, M.D., Professor, Department of
Psychiatry, Yale University, and a senior investigator on the pilot
trial. "This pilot study has prompted discussions of future studies
to further investigate lofexidine's capabilities in the treatment
of opiate addiction."

In the UK, BritLofex is a leading detoxification agent with more
than 20,000 detoxifications carried out per year and is also used
in outpatient settings, providing another option for areas where
treatment clinics are not available.

Last April, a National Institute on Drug Abuse sponsored study
was halted, i.e., a Phase III trial that was investigating the use
of BritLofex for the treatment of opiate withdrawal symptoms in
opiate dependent individuals was stopped due to the overwhelming
evidence of efficacy in the BritLofex treatment group as compared
with a placebo group. After a regularly scheduled review of the
trial, the Data Safety Monitoring Board determined that due to the
overwhelming efficacy demonstrated by BritLofex, it would be
unnecessary and unethical to the placebo group to continue the
clinical trial. Britannia is currently seeking a licensing partner
for BritLofex in the United States.

With the exception of the opiate antagonist used in the study
(which is associated with adherence problems in this population),
no other medication has been found to prevent relapse to heroin
besides lofexidine.

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